The invention relates to cardiac output measurement, and more particularly, to a continuous cardiac output measuring system using pattern recognition.
Cardiac Output (CO) is used clinically to evaluate cardiac function in critically ill patients, aid in the diagnosis of cardiovascular disease, and guide therapeutic decisions in complex clinical situations. Continuous determinations of cardiac output are especially important for monitoring acutely ill patients, because their hemodynamic status may vary significantly during a short period of time. CO is defined as the volume of blood ejected by the left ventricle into the aorta per unit of time. Cardiac output is a function of the contractility of the ventricle, the afterload (i.e., the load the heart pumps against) and the preload (i.e., the volume of blood in the heart before it contracts). Cardiac output varies according to the body's needs for oxygen and nutrients. An average cardiac output for the population at large is 5.6 liters per minute. Another measure of heart output is cardiac index (CI), which is the cardiac output per square meter of body surface area. A normal human being of 70 kg. has a body surface area of about 1.7 square meters (m.sub.2), giving a CI of about 3.0 liters/m.sup.2 per minute. CI, like CO, varies with age. At 10 years of age CI is greater than 4 liters/m.sup.2 per minute, while at the age of 80 CI declines to about 2.4 liters/m.sup.2 per minute.
Prior systems have attempted to measure cardiac output both in a discrete and in a continuous manner. There are many desired features that a cardiac output measuring device should possess. For one, a cardiac output measuring device should have automated, continuous (in real-time) output measurements for the cardiac output. In addition, the cardiac output measurement device should have low invasiveness, present minimal risk to the patient, and not interfere with the desired hemodynamic measurement of the patient. Finally, the system should be relatively inexpensive to manufacture, easy to use in the clinical setting, accurate and compact.
A variety of cardiac output measurement devices are known in the art, all of which have certain disadvantages. One of the oldest techniques involves the Fick method, based on the theoretical principles described by Adolph Fick in 1870, that the total uptake or release of any substance by an organ is the product of blood flow to an organ and the arteriovenous concentration difference of the substance. One measurement technique consists of having the patient breathe pure O.sub.2 from a spirometer with a CO.sub.2 absorber, and measuring O.sub.2 uptake directly from the net gas flux. Two catheters, one in the pulmonary artery and one in the brachial or femoral artery are used to sample mixed pulmonary artery and arterial blood to determine O.sub.2 concentrations in the bloodstream. While the Fick method has the potential for high accuracy, most clinicians achieve actual accuracies in the range of 5% to 10%. Its disadvantages include: the patient's cardiac output and O.sub.2 consumption must be constant over several minutes for accurate measurement; more than one catheter is required, which increases the risk of infection; a significant volume of blood is used by the test making it inconvenient for repeated cardiac output measurements, especially on infants or acutely ill patients; and, the monitors used to analyze gas concentrations are often bulky and these monitors are often not located near the patient, making real-time analysis difficult.
Another cardiac output measuring technique is the indicator dilution technique, which involves the injection of a predetermined amount of indicator dye into the right atrium, and measuring the dilution of the dye downstream. The average volume flow of blood flow is inversely proportional to the integrated area under the dilution curve. Besides using dye as an indicator, a saline solution can be used and the temperature and conductivity of the saline solution can be measured downstream for the same effect. The main disadvantage of indicator dilution techniques is recirculation of the indicator after the first measurement, which makes it difficult to make repeated measurements. For example, if indocyanine dye is used, only 50% of the dye is removed by the kidneys 10 minutes after injection. If saline is used as an indicator, repeated measurements can dilute the patient's blood supply. The use of catheters in this technique also increases the likelihood of infection, introduction of an air embolism or potential electrical hazard.
Other cardiac output measuring techniques that are invasive of the body include electromagnetic flow probe measurements from an electromagnetic flow probe surgically implanted onto a blood vessel. While continuous and instantaneous blood flow measurements are possible, measurement accuracy is dependent on vessel preparation during the implantation, and the surgery itself is a high risk procedure.
Non-invasive approaches have been developed to avoid the risks associated with invasive procedures; however, when information concerning patient hemodynamic variables such as central pressure, pulmonary artery pressure, capillary wedge pressure, and systemic arterial pressure is required, an invasive technique must be used. One noninvasive approach includes the use of a transthoracic impedance transducer which measures impedance changes in the thorax to calculate blood flow. The accuracy of this technique is reduced by patient movement which can affect the output. Doppler ultrasound methods are generally the most non-invasive means to measure blood flow, but are expensive and bulky, and may require some invasive measurements to completely assess the patient's hemo-dynamic status. In addition, the location of the ultrasound probes has to be exact and may interfere with other probes in the thoracic cavity.
Other attempts at determining the cardiac output in a relatively non-invasive manner have attempted to do so by taking integrals of the arterial pressure waveform over time, which can be approximately related to stroke volume and hence cardiac output. However, it must be stressed that stroke volume is a time-varying, non-linear function of arterial pressure, as well as other cardiovascular variables such as arterial resistance, arterial compliance, ventricular contractility and heart rate. Prior methods can be termed "pulse contour" methods and attempt to solve the non-linear arterial pressure function by replacing it with a simple, timeinvariant, linear differential equation. The simplified differential equation, however, is only an approximation to the actual arterial function, and may not accurately represent the actual arterial pressure function. For example, it has been found that at lower pressures in young and healthy individuals, compliance is relatively linear. However, even at lower pressures, compliance is nonlinear in many older individuals. Also, at higher pressures in both young and old individuals, compliance can be extremely nonlinear thus resulting in inaccurate cardiac output measurement results with these methods.
Referring to FIG. 1 in which a pressure waveform 10 is shown, the events of the cardiac cycle as they relate to pressure waveforms in the arteries will now be described. The cardiac cycle can be divided into two periods, systole 12 and diastole 14, and these periods can be further subdivided. Systole 12 is the period of the cardiac cycle during which the heart contracts. Ventricular systole lasts about 0.3 seconds, while atrial systole lasts about 0.1 seconds. Diastole 14 is the period between two contractions of the heart, when the muscle of the heart relaxes and allows the chambers to fill with blood. Ventricular diastole lasts about 0.5 seconds in a normal heart rate of about 70 beats per minute. In the normal young adult the pressure peak at systole is about 120 mm. Hg, while the pressure at the nadir of the cycle, at diastole, is about 80 mm.Hg. The difference between these two pressures, 40 mm.Hg, is the pulse pressure. The FIG. also presents a dicrotic notch 16 in the pressure waveform 10.
In general, the shape of an arterial pressure waveform 10 is due to a variety of factors some of which are nonlinear and are related in a non-linear manner, and include different rates of transmission and distortion in the components of a pressure wave, interference with standing or reflected waves, differences in the elasticity and diameter of arteries, as well as the conversion of kinetic energy to static pressure.
For purposes of illustration only, the cardiac cycle can be simplified and approximated by an RC circuit, where the resistor R and capacitor C are in parallel with a time varying current supply E(t). The voltage drop across the resistor is P.sub.a -P.sub.v This so called Windkessel model of the cardiac cycle, whose differential equation equating flow is represented by: ##EQU1## where: E (t)=flow into the Windkessel model during systole;
P(t)=differential pressure of the arteries compared to the veins (P.sub.a -P.sub.v); PA1 C=Windkessel arterial compliance; and PA1 R=Windkessel peripheral resistance. PA1 t.sub.ED =time at end of diastole. PA1 (1) the relationship between changes in pressure and blood volume is assumed to be linear and constant, which may not be the case in clinical settings; PA1 (2) the Windkessel equation is a linear differential equation with constant coefficients, while arterial pressure is a non-linear function; PA1 (3) for all the above mentioned techniques, an independent measure of stroke volume or cardiac output is required for every patient tested in order to evaluate the proportionality constant. Also, due to the timevarying nature of the variables, repeat calibration is often required during monitoring; PA1 (4) all of the above mentioned techniques require knowledge of a systolic time interval for the determination of the systolic pressure area or end systolic pressure. To calculate the systolic time interval, an accurate measurement of the arterial pulse transmission time is necessary, which is difficult to measure. Some techniques require measurement of the time of the dicrotic notch; however, it is often difficult to accurately determine that time. In addition, the systolic time interval depends on the heart rate and mean arterial pressure; and PA1 (5) most of the above mentioned techniques (excluding Guier's) assume that the diastolic drainage is equal to the arterial uptake. This relationship, however, may be significantly violated during conditions often seen in a real hospital setting, such as irregular heartbeats, aortic valve closure failures and other cardiac arrhythmias.
Solution of this differential equation is assumed to give a representation of the cardiac cycle. The initial conditions are determined by whether the cycle is in systole whereupon the current supply E(t) is assumed to be connected in parallel with the RC circuit, or whether the cycle is in diastole, whereupon it is assumed E(t) is removed from the rest of the circuit by opening a switch. This represents diastolic runoff into the peripheral circulation. The current stored in the capacitor is then discharged through the resistor, and the voltage P(t) (which corresponds to the arterial pressure in the heart) is given by: ##EQU2## where: E.sub.DP =end diastolic pressure; and
However, despite the simple solution to this differential equation, the difficulty in the solution lies with determining the coefficients of peripheral resistance (R) and arterial compliance (C). Lacking these two values, it is impossible to directly integrate the pressure function contour over time to determine cardiac output. As a consequence, most researchers have chosen to use indirect methods of solving the Windkessel equations, in which the stroke volume is determined without explicit knowledge of R and C. Specific approaches include the methods of Hamilton and Remington (1947), Warner (1953) and (1968), Kouchoukos (1970), Bourgeois (1976), Guier (1974), Smith and Wesseling (1974), Brubakk (1980), and the Harley and Herd methods, all of which are known to those skilled in the art. Each of these techniques employs various ratios of integrals of the pressure waveform and a proportionality constant.
Potential problems and sources of error of these pulse contour methods of measuring cardiac output based on the Windkessel equations include:
Hence, those concerned with determining cardiac output and other vascular system characteristics of a patient have recognized the need for an improved, relatively simple, less invasive, and accurate system for continuously determining and displaying data concerning such characteristics. Additionally, those concerned have also recognized the need for a system and method which is more accurate over a variety of patients. The present invention fulfills these needs and others.